# K041137: Newtom 3G QR-DVT 9000

- Pathway: 510(k) (Special)
- Applicant: Aperio Services, LLC
- Decided: May 14, 2004 after 14 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003787 (2001). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003787: Newtom QR-DVT 9000, Aperio Services, LLC (2001) Summary page 1.

## Most influential descendants
- K072357: Newtom VG Computed Tomography X-Ray System (2007), 2 descendants of its own
- K133797: Qmaster-H/Revo (2014), 0 descendants of its own
- K110260: Newtom 5G / Newtom 5G Version FP (2011), 0 descendants of its own

## Indications for use
The NewTom QR-DVT 9000 Computed Tomography X-ray System is a dedicated X-Ray imaging device that acquires a 360-degree rotational X-Ray sequence for use in diagnostic support in odontoiatric radiology (with a particular reference to patient evaluation and the monitoring of implantations) and in the field of maxillofacial surgery. This is the same intended use as previously cleared for the NewTom QR-DVT 9000 Computed Tomography X-ray System, [510 (k) #K003787]. The NewTom QR-DVT 9000 accomplishes this task by reconstructing a three-dimensional matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and three-dimensional images.

Source page: https://510kreport.com/device/K041137
Methodology: https://510kreport.com/methodology